Trial Suggests New Drug Could Cut Hepatitis C Treatment Time

Vertex Pharmaceuticals Inc has released early results of a trial on new hepatitis C drug telaprevir that suggest it could significantly reduce the treatment time for the disease.The planned interim results of the PROVE 1 clinical trial on telaprevir were announced at Barcelona on Saturday at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL).
PROVE 1 is the first trial to evaluate short-duration treatment using the investigational hepatitis C protease inhibitor telaprevir (TVR or VX-950) with pegylated interferon (peg-IFN) and ribavirin (RBV) in genotype 1-infected hepatitis C patients who have not received treatment for hepatitis before.

The trial showed a high rate of rapid viral response (RVR) in patients treated with telaprevir, and a low rate of on-treatment viral breakthrough, and suggests that some patients can be cleared of the virus with 12 weeks of telaprevir-based therapy.

Telaprevir is a joint development between global biotech company Vertex Pharmaceuticals Inc and Tibotec Pharmaceuticals Ltd, of Cork, Ireland.

Dr John McHutchison, Principal Investigator of the PROVE 1 study and Director of Gastroenterology and Hepatology Research at Duke Clinical Research Institute, based in Durham, North Carolina, US, said:

"The high rates of RVR observed in the telaprevir groups in PROVE 1, and the fact that some patients have remained persistently viral negative 20 weeks after stopping the 12 weeks of telaprevir-based therapy, suggest that we may be able to shorten the treatment duration in genotype 1 HCV patients."

He suggested there is a strong possibility that high sustained viral response (SVR) rates could be achieved with treatments lasting 24 weeks.

"We look forward to 24 week follow-up data from the initial group of patients who stopped treatment at 12 weeks, and follow-up data from patients in the study who received 24 weeks of treatment," he added.

Adverse reactions caused 11 per cent of the 175 patients given telaprevir-based therapy to discontinue treatment, compared with 3 per cent in a placebo group. Symptoms of adverse events that led to discontinuation included rash, gastrointestinal problems and
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